Journal of pharmaceutical sciences最新文献_第7页

2025 Editorial Advisory Board (EAB) appointments 2025年编辑顾问委员会（EAB）任命。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-03-01 DOI: 10.1016/j.xphs.2024.12.016

Kenneth L. Audus

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Editorial Advisory Board 编辑顾问委员会

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-03-01 DOI: 10.1016/S0022-3549(25)00162-5

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2025 Scientific Advisors to the Editors (SAEs) appointments 2025年编辑科学顾问（sae）任命。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-03-01 DOI: 10.1016/j.xphs.2024.12.015

Kenneth L. Audus

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Current industry practices on closed system drug-transfer devices for parenteral drug products 肠外用药封闭系统药物转移装置的现行行业规范。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-03-01 DOI: 10.1016/j.xphs.2025.01.019

Isabella de Jong , David Cheng Thiam Tan , Christian Lehermayr , Mollie Daugherty , Vasco Filipe , Matthias Winzer , Stanley C. Kwok , Annette Medina , Allison Guy , Twinkle Christian , Shubhadra N. Singh , Soumendu Bhattacharya , Serene Jabary

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Centrifuge siliconization of primary container systems 主容器系统的离心硅化。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-03-01 DOI: 10.1016/j.xphs.2025.01.025

Brian Wong , Kaitlin Wang , Kavin Kowsari, Yongchao Su, William Forrest, Jeffrey Givand, Guangli Hu

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Freezing-induced protein aggregation in a bispecific antibody: Characterization and mechanistic insights 冷冻诱导的双特异性抗体蛋白聚集：特性和机制的见解。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-27 DOI: 10.1016/j.xphs.2025.103711

Xiaofeng Lu , Blanca Domingo-Yenes , Noah Cohen , Elissa Grzincic

{"title":"Freezing-induced protein aggregation in a bispecific antibody: Characterization and mechanistic insights","authors":"Xiaofeng Lu , Blanca Domingo-Yenes , Noah Cohen , Elissa Grzincic","doi":"10.1016/j.xphs.2025.103711","DOIUrl":"10.1016/j.xphs.2025.103711","url":null,"abstract":"<div><div>Aggregation or formation of high molecular weight species (HMWS) was observed with a pharmaceutical bispecific antibody (BsAb) during freeze-thaw and storage at −20 °C, but not at −80 °C. Several freezing stresses that may drive the protein aggregation were evaluated, including temperature, freeze concentration, ice formation, cooling rate, and cold denaturation. Experiments designed to identify the main aggregation mechanism and the drivers revealed that protein dimerization is the main mechanism and protein interaction with ice is the main driver of the protein aggregation. Additionally, higher molecular mobility at −20 °C (compared to −80 °C) propagates the aggregation. Molecular structure modeling of the single-chain variable fragment (scFv) revealed the steric clashes between amino acid residues at the core of the interface between the variable heavy (VH) and variable light (VL) domains, could be an intrinsic driver of the protein aggregation. The study presents an interesting case of sequence-specific product quality liability for bispecifics and provides insights into strategies for prevention and mitigation of the liability.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 5","pages":"Article 103711"},"PeriodicalIF":3.7,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Trans-resveratrol-loaded nanostructured lipid carrier formulations for pulmonary drug delivery using medical nebulizers 反式白藜芦醇负载的纳米结构脂质载体配方用于医用雾化器的肺部药物输送。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-27 DOI: 10.1016/j.xphs.2025.103713

Iftikhar Khan , Maria Sabu , Nozad Hussein , Huner Omer , Chahinez Houacine , Wasiq Khan , Abdelbary Elhissi , Sakib Yousaf

{"title":"Trans-resveratrol-loaded nanostructured lipid carrier formulations for pulmonary drug delivery using medical nebulizers","authors":"Iftikhar Khan , Maria Sabu , Nozad Hussein , Huner Omer , Chahinez Houacine , Wasiq Khan , Abdelbary Elhissi , Sakib Yousaf","doi":"10.1016/j.xphs.2025.103713","DOIUrl":"10.1016/j.xphs.2025.103713","url":null,"abstract":"<div><div>Aerosolization is a non-invasive approach of delivering drugs for both localized and systemic effects, specifically pulmonary targeting. The aim of this study was to deliver trans-resveratrol (TR) as an anti-cancer drug entrapped in a new generation versatile carriers nanostructured lipid carrier (NLC) to protect degradation and improve bioavailability <em>via</em> medical nebulizers. Twelve TR-NLC (i.e., F1-F12) formulations were prepared using different combinations and ratios of formulation ingredients <em>via</em> hot high-pressure homogenization. Upon analysis, formulations F1 and F2 demonstrated a particle size of <185 nm, a polydispersity index (PDI) <0.25, Zeta potential values of ∼30 mV and an entrapment efficiency >94%. The aerosolization performance of the F1 and F2 formulations was performed <em>via</em> a next generation impactor (NGI), using medical nebulizers. The air jet nebulizer demonstrated lower drug deposition in the earlier stages (1-2) and significantly higher deposition in the latter stages 3-5 (for both formulations), targeting middle to lower lung deposition. Moreover, the air jet nebulizer exhibited significantly higher emitted dose (ED) (87.44 ± 3.36%), fine particle dose (FPD) (1652.52 ± 9.68 µg) fine particle fraction (FPF) (36.25 ± 4.26%), and respirable fraction (RF) (93.41 ± 4.03%) when the F1 formulation was used as compared to the F2 formulation. Thus, the TR-NLC F1 formulation and air jet nebulizer were identified as the best combination for the delivery and targeting peripheral lungs.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 5","pages":"Article 103713"},"PeriodicalIF":3.7,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Impact of Dry Ice Exposure on pH Change During Biologics Transport and Mitigation Strategies. 干冰暴露对生物制品运输过程中 pH 值变化的影响及缓解策略。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-27 DOI: 10.1016/j.xphs.2025.103709

Yu Wang, Dihan Su, Yu Yang, Xinyu Huang, Zhaowei Jin, Quanmin Chen, Hongbing Wu, Jeremy Guo

{"title":"The Impact of Dry Ice Exposure on pH Change During Biologics Transport and Mitigation Strategies.","authors":"Yu Wang, Dihan Su, Yu Yang, Xinyu Huang, Zhaowei Jin, Quanmin Chen, Hongbing Wu, Jeremy Guo","doi":"10.1016/j.xphs.2025.103709","DOIUrl":"https://doi.org/10.1016/j.xphs.2025.103709","url":null,"abstract":"<p><p>Cold chain with dry ice is extensively used in the pharmaceutical transportation. Containers designed for cryo-storage are often placed contact with CO<sub>2</sub> released from dry ice, yet the effects of CO<sub>2</sub> on drug formulations during pharmaceutical transportation are infrequently discussed. In this study, the impact of pH change on various containers and buffer systems, the ingress pathway of CO<sub>2</sub> and the mitigation control strategies were investigated. The findings revealed notable pH changes in various types of containers with 5 mL polycarbonate bottles, 150 mL Corning bottles, and plastic tubes, while glass vials with stopper and capping maintained better pH stability. Buffer systems with a higher initial pH, such as phosphate and Tris buffers, were more prone to disturbances. Additionally, buffers with higher ionic strength showed an enhanced capacity to counteract pH reductions. The probability of CO<sub>2</sub> ingress pathway largely depends on the integrity of the sealing approaches at low temperature. Control strategy involving temporary uncapping during thawing and the use of secondary packaging sealed with an aluminum foil bag during transportation proved effective. This research expounded the impact of dry ice on pH change and strategic control measures within pharmaceutical supply chains, aiming to improve understanding of the variables related to container use in scenarios involving dry ice transportation.</p>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":"103709"},"PeriodicalIF":3.7,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A target affinity enrichment workflow to characterize critical post-translational modifications within therapeutic antibodies 表征治疗性抗体中关键翻译后修饰的目标亲和力富集工作流程。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-27 DOI: 10.1016/j.xphs.2025.103710

Jethro E. Prinston , Wenjing Peng , Kathleen Provoncha , Youmi Moon , Evan Koufos , Cristinel Sandu , Yue Fu , Yuetian Yan , Shunhai Wang , Ning Li , Jennifer B. Nguyen , Michael P. Rosconi , Erica A. Pyles

{"title":"A target affinity enrichment workflow to characterize critical post-translational modifications within therapeutic antibodies","authors":"Jethro E. Prinston , Wenjing Peng , Kathleen Provoncha , Youmi Moon , Evan Koufos , Cristinel Sandu , Yue Fu , Yuetian Yan , Shunhai Wang , Ning Li , Jennifer B. Nguyen , Michael P. Rosconi , Erica A. Pyles","doi":"10.1016/j.xphs.2025.103710","DOIUrl":"10.1016/j.xphs.2025.103710","url":null,"abstract":"<div><div>The therapeutic efficacy of a monoclonal antibody (mAb) relies on tight and specific binding to its intended target. This interaction may be abrogated or influenced by antibody fragmentation and/or post-translational modifications (PTMs) on or near the paratope. PTMs with reduced target affinity are considered impactful to drug quality and should be well-characterized during pharmaceutical development. The task of identifying and characterizing these PTMs can be facilitated by employing a strategy which utilizes semi-preparative affinity chromatography using an immobilized ligand target. Here, we present a proof-of-concept application of this strategy for a therapeutic antibody targeting a Type I cytokine receptor. Briefly, a sub-molar equivalent of the therapeutic antibody was applied to a column containing the immobilized receptor target. Fractions containing antibody variants with differential affinity to target were collected and evaluated by a panel of extended characterization assays, including size, charge, target-binding affinity, and cell-based potency. This approach specifically targets variants based on ligand affinity and enabled the identification of novel and specific PTMs, including Fab glycosylation, which were shown to be impactful to drug quality and could be considered critical quality attributes (CQAs). Furthermore, characterization of affinity-enriched fractions using assays that are orthogonal and complimentary to those used for release could guide or support the development of such assays which are sufficiently sensitive to detect these PTMs during product release.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 5","pages":"Article 103710"},"PeriodicalIF":3.7,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Strategies of Formulation and Lyophilization Process for Sodium Chloride-Mannitol-Protein-Based Products. 氯化钠-甘露醇蛋白基产品的配方及冻干工艺策略。

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2025-02-26 DOI: 10.1016/j.xphs.2025.01.007

Chenying Lin, Xiaozhang Zhang, Chunsheng Yang, Zhaowei Jin, Jeremy Guo

{"title":"Strategies of Formulation and Lyophilization Process for Sodium Chloride-Mannitol-Protein-Based Products.","authors":"Chenying Lin, Xiaozhang Zhang, Chunsheng Yang, Zhaowei Jin, Jeremy Guo","doi":"10.1016/j.xphs.2025.01.007","DOIUrl":"https://doi.org/10.1016/j.xphs.2025.01.007","url":null,"abstract":"<p><p>Sodium chloride (NaCl) serves as a necessary stabilizer for some proteins, yet it presents an unfriendly eutectic melting temperature and can easily lead to collapse for lyophilized products. Mannitol, serving as bulking agent with property of high eutectic melting point, can provide good mechanical support for lyophilized cake to avoid collapse, therefore it is applied for lyophilized formulations containing NaCl. However, the combination of NaCl and mannitol in formulations often results in structural collapse in lyophilization process due to unproper ratio or lyophilization recipe. In this study, the strategy to improve cake appearance with formulations containing NaCl and mannitol has been explored. The suitable lyophilization formulation compositions and lyophilization process parameters have been proposed with acceptable protein stability. Furthermore, the possibility of mutual inhibition by NaCl and mannitol crystallization is revealed by result of XRD, in which various mannitol crystal forms are observed. It is speculated that protein concentration and lyophilization process parameters are main factors to affect mannitol crystal forms. Our studies not only provide insights into the crystallization behaviors in NaCl-mannitol-protein-based formulations, but also find the strategies to improve the appearance of their lyophilized biopharmaceuticals, facilitating their widespread applications in pharmaceutical development.</p>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0